Trial Outcomes & Findings for Global Prospective Case Series Using a Single-Use Duodenoscope (NCT NCT04103749)
NCT ID: NCT04103749
Last Updated: 2023-12-12
Results Overview
The ability to complete the ERCP procedure for the intended indication(s); outcome reported as "success" or "failure". Examples include but are not limited to: biliary stent placement, pancreatic stent placement, sphincterotomy, and clearance of bile duct stones.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
551 participants
Primary outcome timeframe
Procedure success is assessed at the end of the procedure (within 24 hours on study day 1).
Results posted on
2023-12-12
Participant Flow
Participant milestones
| Measure |
Exalt DScope 02
Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form.
Exalt Model D Single-Use Duodenoscope: Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.
|
|---|---|
|
Overall Study
STARTED
|
551
|
|
Overall Study
COMPLETED
|
495
|
|
Overall Study
NOT COMPLETED
|
56
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Exalt DScope 02
n=551 Participants
Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form.
Exalt Model D Single-Use Duodenoscope: Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.
|
|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 15.9 • n=551 Participants
|
|
Sex/Gender, Customized
Sex, Male
|
281 Participants
n=551 Participants
|
|
Sex/Gender, Customized
Sex, Female
|
269 Participants
n=551 Participants
|
|
Sex/Gender, Customized
Sex, other
|
1 Participants
n=551 Participants
|
|
Region of Enrollment
Canada
|
25 participants
n=551 Participants
|
|
Region of Enrollment
Netherlands
|
25 participants
n=551 Participants
|
|
Region of Enrollment
Singapore
|
25 participants
n=551 Participants
|
|
Region of Enrollment
Hong Kong
|
25 participants
n=551 Participants
|
|
Region of Enrollment
United States
|
276 participants
n=551 Participants
|
|
Region of Enrollment
Italy
|
25 participants
n=551 Participants
|
|
Region of Enrollment
South Africa
|
25 participants
n=551 Participants
|
|
Region of Enrollment
Australia
|
25 participants
n=551 Participants
|
|
Region of Enrollment
France
|
25 participants
n=551 Participants
|
|
Region of Enrollment
Germany
|
25 participants
n=551 Participants
|
|
Region of Enrollment
India
|
50 participants
n=551 Participants
|
|
American Society of Anesthesiology physical status
I
|
66 Participants
n=551 Participants
|
|
American Society of Anesthesiology physical status
II
|
198 Participants
n=551 Participants
|
|
American Society of Anesthesiology physical status
III
|
250 Participants
n=551 Participants
|
|
American Society of Anesthesiology physical status
IV
|
32 Participants
n=551 Participants
|
|
American Society of Anesthesiology physical status
V
|
0 Participants
n=551 Participants
|
|
American Society of Anesthesiology physical status
Not assessed
|
5 Participants
n=551 Participants
|
|
Relevant gastrointestinal medical history
Bile duct stones/gallstones(current)
|
168 participants
n=551 Participants
|
|
Relevant gastrointestinal medical history
Documented biliary or pancreatic stricture, unresolved
|
124 participants
n=551 Participants
|
|
Relevant gastrointestinal medical history
Current immunosuppression (any cause)
|
71 participants
n=551 Participants
|
|
Relevant gastrointestinal medical history
Chronic pancreatitis
|
68 participants
n=551 Participants
|
|
Relevant gastrointestinal medical history
Pancreatic tumor
|
63 participants
n=551 Participants
|
|
Relevant gastrointestinal medical history
Abnormal image finding
|
60 participants
n=551 Participants
|
|
Relevant gastrointestinal medical history
Cholangitis (current)
|
53 participants
n=551 Participants
|
|
Relevant gastrointestinal medical history
Cholangiocarcinoma
|
46 participants
n=551 Participants
|
|
Relevant gastrointestinal medical history
Primary sclerosing cholangitis
|
24 participants
n=551 Participants
|
|
Relevant gastrointestinal medical history
Other gastrointestinal cancer
|
22 participants
n=551 Participants
|
|
Relevant gastrointestinal medical history
Pancreatic stones (current)
|
22 participants
n=551 Participants
|
|
Relevant gastrointestinal medical history
Recurrent cholangitis
|
21 participants
n=551 Participants
|
|
Relevant gastrointestinal medical history
Hepatic tumor
|
18 participants
n=551 Participants
|
|
Relevant gastrointestinal medical history
Hepatitis
|
11 participants
n=551 Participants
|
|
Relevant gastrointestinal medical history
Pancreatic pseudocyst
|
9 participants
n=551 Participants
|
|
Relevant gastrointestinal medical history
Known history of Multidrug-resistant organisms (MDRO) colonization
|
2 participants
n=551 Participants
|
|
Relevant gastrointestinal medical history
Known current MDRO colonization
|
2 participants
n=551 Participants
|
|
Relevant gastrointestinal medical history
Current documented bacterial infection, other than cholangitis
|
8 participants
n=551 Participants
|
|
Relevant gastrointestinal medical history
Other
|
146 participants
n=551 Participants
|
PRIMARY outcome
Timeframe: Procedure success is assessed at the end of the procedure (within 24 hours on study day 1).The ability to complete the ERCP procedure for the intended indication(s); outcome reported as "success" or "failure". Examples include but are not limited to: biliary stent placement, pancreatic stent placement, sphincterotomy, and clearance of bile duct stones.
Outcome measures
| Measure |
Exalt DScope 02
n=551 Participants
Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form.
Exalt Model D Single-Use Duodenoscope: Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.
|
|---|---|
|
Number of Participants With Successful ERCP Procedure
|
529 Participants
|
SECONDARY outcome
Timeframe: Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure on study day 1.Endoscopist ratings of overall satisfaction with the single-use duodenoscope on a scale of 1 (worst) to 10 (best)
Outcome measures
| Measure |
Exalt DScope 02
n=551 Participants
Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form.
Exalt Model D Single-Use Duodenoscope: Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.
|
|---|---|
|
Endoscopist Rating
|
8.0 Score on a scale
Interval 1.0 to 10.0
|
SECONDARY outcome
Timeframe: Incidence of crossover is monitored throughout the procedure (within 24 hours on study day 1).The need to use a reusable duodenoscope for any task which cannot be adequately performed with the Exalt single-use duodenoscope is considered a crossover.
Outcome measures
| Measure |
Exalt DScope 02
n=551 Participants
Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form.
Exalt Model D Single-Use Duodenoscope: Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.
|
|---|---|
|
Number of Participants With a Crossover From Exalt Single-use Duodenoscope to Reusable Duodenoscope
|
37 Participants
|
SECONDARY outcome
Timeframe: SAEs are assessed through 30 days after the procedure.Evaluation of serious adverse events (SAEs) related to the device and/or the procedure through 30 days after the ERCP or other duodenoscope based procedures
Outcome measures
| Measure |
Exalt DScope 02
n=551 Participants
Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form.
Exalt Model D Single-Use Duodenoscope: Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.
|
|---|---|
|
Number of Adverse Events (SAEs) Related to the Device and/or the Procedure
|
46 Events
|
Adverse Events
Exalt DScope 02
Serious events: 85 serious events
Other events: 75 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Exalt DScope 02
n=551 participants at risk
Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form.
Exalt Model D Single-Use Duodenoscope: Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Cardiac disorders
Cardiac arrest
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.73%
4/551 • Number of events 4 • 30 Days
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Gastrointestinal disorders
Gastric perforation
|
0.36%
2/551 • Number of events 2 • 30 Days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.73%
4/551 • Number of events 4 • 30 Days
|
|
Gastrointestinal disorders
Haematemesis
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Gastrointestinal disorders
Pancreatitis
|
3.4%
19/551 • Number of events 19 • 30 Days
|
|
Gastrointestinal disorders
Pneumoretroperitoneum
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
General disorders
Complication associated with device
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
General disorders
Disease progression
|
0.54%
3/551 • Number of events 3 • 30 Days
|
|
General disorders
Non-cardiac chest pain
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
General disorders
Pyrexia
|
0.54%
3/551 • Number of events 3 • 30 Days
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.36%
2/551 • Number of events 2 • 30 Days
|
|
Hepatobiliary disorders
Cholangitis
|
1.1%
6/551 • Number of events 6 • 30 Days
|
|
Hepatobiliary disorders
Cholecystitis
|
0.54%
3/551 • Number of events 3 • 30 Days
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.36%
2/551 • Number of events 2 • 30 Days
|
|
Infections and infestations
Bacteraemia
|
0.36%
2/551 • Number of events 2 • 30 Days
|
|
Infections and infestations
Clostridium difficile infection
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Infections and infestations
Escherichia bacteraemia
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Infections and infestations
Klebsiella sepsis
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Infections and infestations
Pneumonia
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Infections and infestations
Post procedural pneumonia
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Infections and infestations
Pseudomonas peritonitis
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Infections and infestations
Retroperitoneal abscess
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Infections and infestations
Sepsis
|
0.91%
5/551 • Number of events 5 • 30 Days
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.36%
2/551 • Number of events 2 • 30 Days
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.91%
5/551 • Number of events 5 • 30 Days
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.73%
4/551 • Number of events 4 • 30 Days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal cancer metastatic
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Renal and urinary disorders
Acute kidney injury
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Vascular disorders
Hypotension
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.18%
1/551 • Number of events 1 • 30 Days
|
Other adverse events
| Measure |
Exalt DScope 02
n=551 participants at risk
Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form.
Exalt Model D Single-Use Duodenoscope: Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.54%
3/551 • Number of events 3 • 30 Days
|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
25/551 • Number of events 25 • 30 Days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.54%
3/551 • Number of events 3 • 30 Days
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Gastrointestinal disorders
Flatulence
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.36%
2/551 • Number of events 2 • 30 Days
|
|
Gastrointestinal disorders
Nausea
|
1.5%
8/551 • Number of events 8 • 30 Days
|
|
Gastrointestinal disorders
Oral pain
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Gastrointestinal disorders
Pancreatitis
|
0.36%
2/551 • Number of events 2 • 30 Days
|
|
Gastrointestinal disorders
Vomiting
|
0.73%
4/551 • Number of events 4 • 30 Days
|
|
General disorders
Fatigue
|
0.36%
2/551 • Number of events 3 • 30 Days
|
|
General disorders
Oedema peripheral
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
General disorders
Pain
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
General disorders
Pyrexia
|
0.91%
5/551 • Number of events 5 • 30 Days
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Hepatobiliary disorders
Haemobilia
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Hepatobiliary disorders
Jaundice
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Immune system disorders
Drug hypersensitivity
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Infections and infestations
COVID-19
|
0.36%
2/551 • Number of events 2 • 30 Days
|
|
Infections and infestations
Klebsiella infection
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Infections and infestations
Oral herpes
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Infections and infestations
Respiratory tract infection
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Infections and infestations
Urinary tract infection
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Injury, poisoning and procedural complications
Post procedural fever
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.54%
3/551 • Number of events 3 • 30 Days
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.91%
5/551 • Number of events 5 • 30 Days
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.36%
2/551 • Number of events 2 • 30 Days
|
|
Investigations
Blood pressure increased
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Investigations
White blood cell count increased
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Nervous system disorders
Dizziness
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Nervous system disorders
Headache
|
0.36%
2/551 • Number of events 2 • 30 Days
|
|
Product Issues
Device occlusion
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.91%
5/551 • Number of events 5 • 30 Days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Investigations
Weight decreased
|
0.18%
1/551 • Number of events 1 • 30 Days
|
|
Hepatobiliary disorders
Cholangitis
|
0.18%
1/551 • Number of events 1 • 30 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A contractual agreement is in place between the PI and the Sponsor that restricts the right to discuss or publish trial results without prior review by the Sponsor
- Publication restrictions are in place
Restriction type: OTHER